Dexferrum Injection Dosage

Oral iron should be discontinued prior to administration of Dexferrum.

Dosage:

I.Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state.

After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count.

Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb).

Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss.

TOTAL DEXFERRUM® REQUIREMENT FOR HEMOGLOBIN RESTORATION AND IRON STORES REPLACEMENT*

Milliliter Requirement of Dexferrum Based On Observed
Hemoglobin of

PATIENT
LEAN BODY
WEIGHT

3
(g/dl)

4
(g/dl)

5
(g/dl)

6
(g/dl)

7
(g/dl)

8 (g/dl)

9 (g/dl)

10 (g/dl)

kg

lb

*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).

5

11

3

3

3

3

2

2

2

2

10

22

7

6

6

5

5

4

4

3

15

33

10

9

9

8

7

7

6

5

20

44

16

15

14

13

12

11

10

9

25

55

20

18

17

16

15

14

13

12

30

66

23

22

21

19

18

17

15

14

35

77

27

26

24

23

21

20

18

17

40

88

31

29

28

26

24

22

21

19

45

99

35

33

31

29

27

25

23

21

50

110

39

37

35

32

30

28

26

24

55

121

43

41

38

36

33

31

28

26

60

132

47

44

42

39

36

34

31

28

65

143

51

48

45

42

39

36

34

31

70

154

55

52

49

45

42

39

36

33

75

165

59

55

52

49

45

42

39

35

80

176

63

59

55

52

48

45

41

38

85

187

66

63

59

55

51

48

44

40

90

198

70

66

62

58

54

50

46

42

95

209

74

70

66

62

57

53

49

45

100

220

78

74

69

65

60

56

52

47

105

231

82

77

73

68

63

59

54

50

110

242

86

81

76

71

67

62

57

52

115

253

90

85

80

75

70

64

59

54

120

264

94

88

83

78

73

67

62

57

The total amount of Dexferrum in mL required to treat the anemia and replenish iron stores may be approximated as follows:

Adults and Children over 15 kg (33 lbs): See Dosage Table. Alternatively the total dose may be calculated:

Based on: Desired Hb = the target Hb in g/dl. (Normal Hb for Children 15 kg or less is 12 g/dl)

W = Weight in kg.

To calculate a patient's weight in kg when lbs are known:

patient's weight in pounds

=

weight in kilograms

2.2

II.Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis.

Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values.

Quantitative estimates of the individual's periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose.

The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron:

Replacement iron (in mg) = Blood loss (in mL) x hematocrit

Example:

Blood loss of 500 mL with 20% hematocrit

Replacement Iron = 500 x 0.20 = 100 mg

Dexferrum dose

= 100 mg =

2 mL

50

Administration: The total amount of Dexferrum required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage).

Dexferrum is administered by intravenous injection. PRIOR TO THE FIRST DEXFERRUM THERAPEUTIC DOSE, ADMINISTER A TEST DOSE OF 0.5 ML INTRAVENOUSLY (See BOXED WARNING and PRECAUTIONS). ADMINISTER THE TEST DOSE AT A GRADUAL RATE OVER AT LEAST FIVE MINUTES. Although anaphylactic reactions known to occur following Dexferrum administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Dexferrum is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

If no adverse reactions are observed, Dexferrum can be given according to the following schedule until the calculated total amount required has been reached. Each day's dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients.

NOTE: Do not mix Dexferrum with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

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